Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

National Cancer Institute (NCI)

Status: Completed

Conditions: Lymphoma

Treatments: Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00020072

CDR0000067694

NCI-00-C-0068

Details and patient eligibility

About

RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma.

PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.

Full description

OBJECTIVES:

• Identify gene expression patterns in malignant T cells that can be used to diagnose cutaneous T-cell lymphoma.
• Determine the patterns of gene expression that distinguish normal skin-homing T cells from malignant T cells.

OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior treatment (yes vs no).

All patients receive a physical examination, and a medical history is taken. Patients with Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated and patterns of gene expression in the malignant T cells are compared to those in normal skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 40 patients (20 per disease stratum) will be accrued for this study within 2 years.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR

• Immunologically proven Sezary syndrome with all of the following:

  • Erythroderma
  • Lymphadenopathy
  • T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR
  • CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells

PATIENT CHARACTERISTICS:

Age:

• 18 to 85

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• HIV-1 and HTLV-1 negative
• No prior intravenous drug use

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 months since prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 2 months since prior electron beam radiotherapy

Surgery:

• Not specified

Other:

• At least 2 weeks since prior topical therapy
• At least 2 months since prior photopheresis
• At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy